MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ ADAPTIS TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680014

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erythema (1840); Failure of Implant (1924); Unspecified Infection (1930); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.

Manufacturer Narrative

Correction h6 method, device, clinical codes the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention and the aftercare.Instruments or implants may become contaminated or flaws in decontamination can occur.This may lead to unsterile instruments or implants.These should not be used.If it goes unnoticed, the use of these devices may cause infection.A medical professional reviewed the received information and noted the following: "i agree that in this case the clinical working hypothesis is a deep, periprosthetic joint infection (pji).This can be concluded from the sparse information.A definitive diagnosis can be confirmed with information of the tissue cultures (if any) that were most likely taken during explantation of the device.Yet, explantation and leaving behind antibiotics-loaden cement spacer, is usually solely done for the two-stage treatment of a pji." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.H3 other text : device not returned.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for infection.Patient came into surgeons office with swelling and redness.The surgeon attempted to treat by aspirating the ankle and treated with antibiotics.Infection persisted, so the surgeon removed the prosthesis and replaced it with an antibiotic spacer.Due to infection and tibial loosening, patient required explantation of prosthesis, implantation of antibiotic cement spacer, and will require a revision.

• Brand Name: INFINITY¿ ADAPTIS TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14686319
• MDR Text Key: 294012459
• Report Number: 3010667733-2022-00209
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 33680014
• Device Catalogue Number: 33680014
• Device Lot Number: 1623145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization